B/A

GUDID 00195291003776

Metal Lined Cermic Twin ROTH .018 LL3 -11°T +5°A 5PK

Flexmedics

Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic
Primary Device ID00195291003776
NIH Device Record Key181db036-2257-4c34-a88d-92771673e21c
Commercial Distribution StatusIn Commercial Distribution
Brand NameB/A
Version Model Number50-L3-8L-V
Company DUNS028853567
Company NameFlexmedics
Device Count5
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone317-346-6655
EmailORDER@GHORTHO.COM
Phone317-346-6655
EmailORDER@GHORTHO.COM
Phone317-346-6655
EmailORDER@GHORTHO.COM
Phone317-346-6655
EmailORDER@GHORTHO.COM
Phone317-346-6655
EmailORDER@GHORTHO.COM
Phone317-346-6655
EmailORDER@GHORTHO.COM
Phone317-346-6655
EmailORDER@GHORTHO.COM
Phone317-346-6655
EmailORDER@GHORTHO.COM
Phone317-346-6655
EmailORDER@GHORTHO.COM
Phone317-346-6655
EmailORDER@GHORTHO.COM
Phone317-346-6655
EmailORDER@GHORTHO.COM
Phone317-346-6655
EmailORDER@GHORTHO.COM
Phone317-346-6655
EmailORDER@GHORTHO.COM
Phone317-346-6655
EmailORDER@GHORTHO.COM
Phone317-346-6655
EmailORDER@GHORTHO.COM
Phone317-346-6655
EmailORDER@GHORTHO.COM

Device Identifiers

Device Issuing AgencyDevice ID
GS100195291003776 [Unit of Use]
GS110195291003773 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NJMBracket, Ceramic, Orthodontic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-07-26
Device Publish Date2020-05-27

Devices Manufactured by Flexmedics

00195291000010 - N/A2023-07-26 CIM CERAMIC TWIN ROTH .022 L1/2 0°T 0°A
00195291000027 - N/A2023-07-26 CIM CERAMIC TWIN ROTH .018 L1/2 0°T 0°A
00195291000232 - N/A2023-07-26 CIM CERAMIC TWIN ROTH .022 UL3 HK 0°T +11°A 4°R
00195291000294 - N/A2023-07-26 CIM CERAMIC TWIN ROTH .018 UL4/5 HK -7°T 0°A
10195291000314 - N/A2023-07-26 CIM CERAMIC TWIN ROTH .018 HK/345 W/CASE
00195291000416 - N/A2023-07-26 CIM CERAMIC TWIN MBT .018 LL4 HK -12°T 0°A
00195291000614 - N/A2023-07-26 CIM CERAMIC TWIN MBT .018 UL4/5 HK -7°T 0°A
00195291000652 - N/A2023-07-26 CIM Ceramic Twin ROTH .022 L1/2 0°T 0°A
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